title: The Scandinavian Propaten(®) trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial.
abstract: OBJECTIVE
  To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study.
  
  
  METHODS
  Eleven Scandinavian centres enrolled 569 patients with chronic functional or critical lower limb ischaemia who were scheduled to undergo femoro-femoral bypass or femoro-poplitaeal bypass. The patients were randomised 1:1 stratified by centre. Patency was assessed by duplex ultrasound scanning. A total of 546 patients (96%) completed the study with adequate follow-up.
  
  
  RESULTS
  Perioperative bleeding was, on average, 370 ml with PTFE grafts and 399 ml with Heparin-bonded PTFE grafts (p = 0.32). Overall, primary patency after 1 year was 86.4% for Hb-PTFE grafts and 79.9% for PTFE grafts (OR = 0.627, 95% CI: 0.398; 0.989, p = 0.043). Secondary patency was 88% in Hb-PTFE grafts and 81% in PTFE grafts (OR = 0.569 (0.353; 0.917, p = 0.020)). Subgroup analyses revealed that significant reduction in risk (50%) was observed when Hb-PTFE was used for femoro-poplitaeal bypass (OR = 0.515 (0.281; 0.944, p = 0.030)), and a significant reduction in risk (50%) was observed with Hb-PTFE in cases with critical ischaemia (OR = 0.490 (0.249; 0.962, p = 0.036)).
  
  
  CONCLUSIONS
  The Hb-PTFE graft significantly reduced the overall risk of primary graft failure by 37%. Risk reduction was 50% in femoro-poplitaeal bypass cases and in cases with critical ischaemia.
authors.affiliation: Vascular Research Unit, Department of Vascular Surgery, Viborg Hospital, 8800 Viborg, Denmark. jes.s.lindholt@viborg.rm.dk
authors.forename: J S
authors.initials: JS
authors.lastname: Lindholt
authors.forename: B
authors.initials: B
authors.lastname: Gottschalksen
authors.forename: N
authors.initials: N
authors.lastname: Johannesen
authors.forename: D
authors.initials: D
authors.lastname: Dueholm
authors.forename: H
authors.initials: H
authors.lastname: Ravn
authors.forename: E D
authors.initials: ED
authors.lastname: Christensen
authors.forename: B
authors.initials: B
authors.lastname: Viddal
authors.forename: T
authors.initials: T
authors.lastname: Flørenes
authors.forename: G
authors.initials: G
authors.lastname: Pedersen
authors.forename: M
authors.initials: M
authors.lastname: Rasmussen
authors.forename: M
authors.initials: M
authors.lastname: Carstensen
authors.forename: N
authors.initials: N
authors.lastname: Grøndal
authors.forename: H
authors.initials: H
authors.lastname: Fasting
mesh_terms: D000368:Aged; D000714:Anastomosis, Surgical / Q000295:instrumentation; D000925:Anticoagulants / Q000494:pharmacology; D001807:Blood Vessel Prosthesis; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D005500:Follow-Up Studies; D006493:Heparin / Q000494:pharmacology*; D006801:Humans; D008297:Male; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D011138:Polytetrafluoroethylene; D011150:Popliteal Artery / Q000601:surgery*; D011474:Prosthesis Design; D012189:Retrospective Studies; D012537:Scandinavian and Nordic Countries; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency / Q000502:physiology*
chemical_list: D000925:Anticoagulants; D011138:Polytetrafluoroethylene; D006493:Heparin